Cleared Traditional

K970518 - ALGOPLAQUE HYDROCOLLOID DRESSING

K970518 · Laboratoires Urgo S.A. · General & Plastic Surgery device
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Mar 1997
Decision
38d
Days
-
Risk

K970518 is an FDA 510(k) clearance for the ALGOPLAQUE HYDROCOLLOID DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Laboratoires Urgo S.A. (St Louis, US). The FDA issued a Cleared decision on March 21, 1997 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laboratoires Urgo S.A. devices

FDA 510(k) Submission Details - K970518

510(k) Number K970518 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 11, 1997
Decision Date March 21, 1997
Days to Decision 38 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 35
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K970518.
HYDRASORB STERILE DRESSING
K973260 · Avitar, Inc. · Oct 1997
LYOCELL WOUND DRESSING/SURGICAL SPONGE
K972458 · Courtaulds Fibers, Inc. · Sep 1997
OPPORTUNITY I.V. START KIT
K971093 · Opportunity, Inc. · Sep 1997
NASP TRANSPARENT DRESSING
K963753 · North American Sterilization & Packaging Co. · Nov 1996
SPYROFLEX PIGMENTED WOUND DRESSING
K963623 · Polymedica Industries, Inc. · Oct 1996
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996